Safeguard Medical Technologies

Safeguard Medical Technologies produces a range of medical devices including surgical and procedural tools like the CORIUS SEAL, which is designed for sealing during medical interventions. They also offer airway management devices such as the 28FR Nasal Airway. Additionally, their portfolio includes patient transport solutions like the TEAM-8 Stretcher and pre-filled Individual First Aid Kits (IFAKs) in two configurations: a black bag and a black back version, intended for emergency medical use.

Safeguard Medical Technologies is based in the United Kingdom. The company’s location is relevant for understanding its regulatory framework, as it operates under UK-based medical device regulations.

Safeguard Medical Technologies’ devices are listed in the eudamed registry, which is the European database for medical devices. Listing in eudamed is required for devices placed on the EU market, ensuring transparency and traceability under EU medical device regulations.

Safeguard Medical Technologies’ devices are classified under EU regulations as either Class I or Class III. The classification determines the regulatory requirements for their design, manufacturing, and post-market surveillance. For example, Class III devices—such as certain surgical seals or high-risk medical tools—require stricter oversight due to their potential higher risk to patient safety.

The classification of a device as Class III under EU regulations is based on its intended purpose and associated risks. For instance, devices like the CORIUS SEAL may be classified as Class III because they are used in critical surgical procedures where failure could pose significant risks to patient health or safety. This classification triggers higher regulatory scrutiny to ensure safety and performance before market placement.